Risperidone 1 Mg Orodispersible Tablets
RISPERIDONE 0.5 mg ORODISPERSIBLE TABLETS RISPERIDONE 1 mg ORODISPERSIBLE TABLETS RISPERIDONE 2 mg ORODISPERSIBLE TABLETS
Risperidone
Medicines forParkinson’s disese (such levodopa)
Water tablets (diuretics) used forhear problems or swelling of parts ofyour
(suc^ as furosemide orchlorothiazide Risperidone taken by itselforwith furosemide, may have an increased ri stroke or deaih in elderly people with
Read all of this leaflet carefully before you
start using this medicine.
• Keep this leafletYou may need to read it
• ff9 ouhavean further uestionsask our doctor orpharmacist.
• This medicine has been prescribed foryou. Do notpass itonto others. It mayharm them, even ifiheir symptoms areihe same
• If any of ihe side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell yourdoctoror pharmacist.
Rifampk
wing m
1. What Risperidone is and what it is used for
2. Before you take Risperidone
3. How to take Risperidone
4. Possible side effects
5. How to store Risperidone
6. Further information
1 WHAT RISPERIDONE IS AND WHAT IT IS USED FOR
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Risperidone belongs to a group of medicines called ‘anti-psychotics’
orfeeUhings that are notthere, believe
hyperactive. Mania occurs In an illness • Short-term treatment (up to 6 weeks) of
themselves or others. Alternative (non-drug) treatments should have been used previously.
ie (blockers ofthe
aciaity of stomach).
Ifyou start or stop taking such medicines may need a differentdose of risperidone. Ifyou arenotsureif any ofthe above app to you, talk to your doctor orpharmacist before using Risperidone.
Taking Risperidone with food and drink
food.You should avoid drinking alcohol w taking Risperidone.
Pregnancy and breast-feeding
• Talk toyour doctor before using Risperidone ifyou are pregnant, trying become prepnantor breast-feeding.Yo
• Shaking, muscle stiffness and problem
Jring tf
monies of their pregnancy): shaking, muscle stiffness and/orweakness, sleepiness, agitation, breathing problems, and difficulty in feeding. Ifyour Babydevelops any of ihese symptoms you may need to contactyour doctor.
2 BEFORE YOU TAKE RISPERIDONE
Do not take Risperidone
• ifyou are allergic (hypersensitive) to risperidone or any of ihe other ingredients of Risperidone (listed in Section 6 below).
tring tr.
Take special care with Risperidone
Checkwiih yourdoctor orpharmacist before taking Risperidone if:
• You have a heart problem. Examples includean irregular heart rhyihm or ifyou are prone to low blood pressure orifyouare
Risperidone may cause low blood pressure. Yourdose mayneed to be adiusted.
• You know of any factors which would
blood pressure, cardiovasculardisorder or
• You have Parkinson’s disease or dementia
wimouttaiKing to yourdoctor first. Important information about some of the ingredients of Risperidone
Risperidone orodispersible tablets contain aspartame (E95l)whichisa source of phenylalanine. Aspartame may be harmful for people with phenylketonuria.
3 HOW TO TAKE RISPERIDONE How much to take For the treatment of schizophrenia
• The usual starting dose is 2 mg per day,
• ....... • ncreased to4mg perdayon
Yourc
experience this while taking Risperidone, contactyourdoctorstraight away.
• You have problems controlling yourbody temperature or overheating
• You have kidney problems
• You have liverproblems
• You have an abnormally high level of the hormone prolactin in yourBlood or ifyou have a tumour, which is possibly dependenton prolactin
• You or someone else in your family hasa history of blood clots, as medicines like
Tell your doctor immediately if you experience
• involuntary rhythmic movements of ihe tongue, mouth and face.Wiihdrawal of
• fever, severe muscle stiffness, sweating or
disorder called "neuroleptic malignant syndrome"). Immediate medical treatment may beneeded.
Ifyou arenotsureif any of the above applies
toyou, talk to yourdoctor orpharmacist
beforeusingRisperidone.
ir depending oi Most people feel be
Elderly people
Children and adolescents
old should not be treated with Risperio
byyour doctordepending c respond to the treatment Most people feel betterwitt
Elderly people
measure your bodyweight.
As diabetes mellitus orworsening of pre-existing diabetes mellitus have been seen with patients taking Risperidone, yourdoctor
patients with pre-existing diabetes mellitus blood glucose should be monitored regularly. Elderly people with dementia
In elderly patients wiih dementia, there is an increased risk ofstroke. You shouldnot take
During treatmentwith risperidone you should frequently see yourdoctor.
Medical treatment should be sought straight
sudden weakness ornumbess ofyour face, armsorlegs, especially ononeside,or slurred speech, even for ashort period of time.These maybe signs ofa stroke.
Children and adolescents
Before treatment is started in conduct
day depending on how much you respond Children and adolescents
old should not be treated with Risperidone
For the treatment of long-standing aggression in people with Alzheimer's dementia Adults (including elderly people)
• Your starting dosewill normally be 0.25mg
• Yourdose may then be gradually adiusted byyour doctordepending on howyou respond to the treatment
• Most people feel betterwith 0.5 mg twice a day. Some patients may need 1 mg
For the treatment of conduct disorder in children and adolescents
The dosewill depend on yourchild’sweigh
If during treatmentwith risperidone tiredness occurs, a change in the time of administration might improve attention difficulties.
Before ireatment is started your, oryour child's bodyweight may be measured anditmaybe regularlymonitored during treatment.
Taking other medicines
are taking or have recently taken any other
It is especially important to talk to your doctor or pharmacist if you are taking any of the following:
to help you calm down ('benzodiazepines) orsome medicines forpain (opiates), medicines for allergy (some antihistamines), as risperidone may increase the sedative effect of all of these
• Medicines that may change ihe electrical activity ofyour heart, sucFi as medicines formalaria, heart rhythm problems (such
some antidepressants orothermedicines
treated with Rispendone forconduct disorder. People with kidney or liver problems
Regardless ofthe disease to be treated, all starting doses and following doses of risperidone should be halved. Dose increases should be slower in ihese patients. Risperidone should be used with caution in
• Medicines that cause low blood potassium
• Medicines to treatelevated blood pressure.
person. The amount ofmedicine you should take is explained underthe 'How much to take’ sub-heading below.
Risperidone orodispersible tablets are fragile. They should not be pushed through the foil in the blister pack as this will cause damage to the tablet. Remove a tablet from the
and eyes along with difficulty breathing, sudden weakness ornumbness ofthe
or instances of SKS
mini-strokes or strokes), involuntary movements of face, arms, or legs, ringing
Rare (affects 1 to 10 users in 10,000):
by gently tearing along the perforations
2. Pull up the edge of he foil and peel foil off completely.
is removed from he packaging.
In a few seconds it begins disintegrating in the mouh and subsequently can be swallowed
emptybefore placing the tablet onhe tongue. You can also put the tablet in a full glass or cup ofwaterand drink it straight away.
• Dandruff
lip swelling/lip inflammation
• Glaucoma, reduced visual clarity, eyelid margin crusting, eye rolling
• Change in consciousness wiih increased body temperature and twitching of
withdrawal syndrome, body temperature decreased
• Fast shallow breathing, trouble breathing during sleep, chronic otitis media
• Obstruction of intestine
• Reduced blood flow to the brain
• Decrease in white blood cells, inappropriate secretion of a hormone that
• Breakdown ofmuscle fibers and pain in muscles (rhabdomyolysis), movement
If you take more Risperidone than you should
• See a doctor rightaway. Take themedicine
If you forget to take Risperidone
• Ifyou forgetto take a dose, take it as soon as you remember it. However, if it is almost time foryournext dose, skip the
* Do not take a double dose (two doses at the same time) to make up for a forgotten
If you stop taking Risperidone
You should notstop taking this medicine unlesstoldtodoso byyour doctor. Your symptoms may return. Ifyour doctordecides
decreased gradually overa few days.
• Coma due to uncontrolled diabetes
• Yellowing ofthe skin and the eyes
• Inflammation of the pancreas
Very rare (affects less than 1 user in 10,000):
• Life threatening complications of uncontrolled diabetes.
Unknown frequency of occurrence (frequency
cannot be estimated from the available data):
• Severe allergic reaction resulting in difficulty in breathing and shock
• No granulocytes (a type ofwhite blood cell to help you against infection)
• Prolonged and painful erection
• Dangerously excessive intake ofwater
ofthis product, askyour doctororpharmacist 4 POSSIBLE SIDE EFFECTS
effects, although noteverybody gets hem'. Very common: affects more than 1 userin 10
Common: affects 1 tolOusers in 100
Uncommon: affects 1to10 users in 1,000
Rare: affects 1 tolOusersin 10,000
Veryrare: affectslessthanluserin
10,000
Not known: frequency cannot be estimated
The following side effects may happen:
Very common (affects more than 1 user in 10):
includes many symptoms. Each individual symptom may occur less frequently than in 1 in 10 people. Parkinsonism includes: increase in saliva secretion orwatery mouth, musculoskeletal stiffness, drooling,
reduced or impaired body movements, no expression on the face, muscle tightness, stiff neck, muscle stiffness, small, shuffling, hurried steps and lack of normal arm movements when walking, persistent blinking in response to tapping ofthe forehead (an abnormal reflex).
• Headache, difficulty falling or staying
Common (affects 1 to 10 users in 100):
to sit still, irritability anxiety, sleepiness, dizziness, poor attention, feeling exhausted, sleep disorder
increased appetite, abdominal pain or
breathing. Ifyou notice any ofthese symptoms seek medical advice immediately.
Long-acting injectable risperidone formulation
The following side effects have been reported with ihe use of long-acting injectable
being treated with long acting injections of risperidone butyou experience any of the
• Abscess underthe skin, tingling pricking
• Decrease in white blood cell counts that helps to protectyou against bacterial
• Sensation ofspinningor swaying
• Slow beating heart high blood pressure
• Toothache, tongue spasm
• Buttockpain
• Weightdecreased.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5 HOW TO STORE RISPERIDONE Keep out of the reach and sight of children.
package.
• Weightincreased,increaseinbody temperature, decreased appetite
• Difficulty breathing, lung infection
breathing passages, blurred vision, nose congestion, nose bleeding, cough
• Muscle spasm, involuntary movements of
pain, swelling of arms and legs, pain in arms and legs
• Rash, skin redness
• Fastbeatingheart,chestpain
• Blood prolactin hormone level increased. Uncommon (affects 1 to 10 users in 1,000):
• Lung infection caused'by inhaling of food into the breathing passages, bladder
stomach infection, eye discharge, yeast
• Abnormal electrical conduction of the heart drop in blood pressure after
after changing body position, abnormal electric activity tracing of ihe heart (ECG), abnormal heart rhylhm, awareness of heart beating, heart rate increased or decreased
pain when passing urine, frequentpassing
Medicines should not be disposed of via wastewater or household waste. Ask your
[pharmacist how to dispose of medicines no onger required. These measures will help to protect the environment.
6 FURTHER INFORMATION
What Risperidone contains
• The active ingredient is risperidone. Each tablet contains 0.5 mg, 1mgor2 mg
• of^eringredients are mannitol (E421), basic butylated methacrylate copolymer, povidone K-25, microcrystalline cellulose, hydroxypropylcellulose, aspartame (E951), crospovidone, red iron oxide (E172), spearmint flavour, peppermint flavour, calcium silicate, magnesium stearate. What Risperidone looks like and contents of the pack
Orodispersible tablets:
Tablets are round, slightly convex, pink marbled tablets.
Contents ofthe packs: 20, 28, 30, 50, 56, 60,
98 orlOO tablets in blisters.
Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer
Krka, d.d., Novo mesto, Smarjeska cesta 6, 8501 Novomesto,Slovenia.
energy and interest
count decreased, low haemoglobin or re> blood cell count (anaemia), increase in eosinophils (special white blood cells), blood creatininephosphokinase increased, decrease in platelets (blood cells that helpyou stop bleeding) Diabetes mellitus, high blood sugar Muscle weakness, muscle pain, ear pain, illing, abnormal
Session,'
itching of sk
: stiffness,
culoskeletal
No menstruation, sexual dysfunction, erectile dysfunction, eiaculation disorder, breast discharge,enlargement of breast in men, decreased sexual drive, irregular menstruation, vaginal discharge
decreased appetite resulting in
eye, increase in tears • Breathing passage disorder, lung
congestion, crackly lung noise, congestion of breathing passages, trouble speaking, difficulty swallowing, cough with sputum,
• Unresponsive to stimuli,loss of
consciousness, sudden swelling of lips